All Clinical Trials

This clinical trial evaluates the characteristics of oral nicotine pouches (ONPs) to determine if they are a comparable substitute to cigarette or smokeless tobacco (ST) products. ONPs contain nicotine but no tobacco and are used primarily by adult tobacco uses in the United States (US). ONPs are recognized by the Food and Drug Administration as having lower risk than combustible cigarettes and are approved as a modified risk tobacco product. While ONPs have lower toxic risk than other tobacco products, acute and longer term harm related to their use has not been studied. Information gathered from this study may identify product characteristics of ONPs that improve successful switching from high-risk cigarettes or ST to lower risk ONPs. Read Less

This phase I/Ib trial tests the safety, side effects, best dose, and effectiveness of ASTX660 (tolinapant) in combination with eribulin mesylate (eribulin) in treating patients with triple negative breast cancer that cannot be removed by surgery (unresectable) or that has spread to nearby tissues or lymph nodes (locally advanced) or to other places in the body (metastatic). Tolinapant may stop the growth of tumor cells by blocking proteins, such as XIAP and cIAP1, needed for tumor cell survival. Chemotherapy drugs, such as eribulin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving tolinapant in combination with eribulin may be safe, tolerable, and/or effective in treating patients with unresectable, locally advanced, or metastatic triple negative breast cancer. Read Less

This study collects and stores blood and tumor samples from patients with malignant melanoma and healthy individuals. The purpose of this study is to gain a better understanding of the causes of melanoma and how melanoma tumors behave. Storing blood and tumor samples for future research may lead to new discoveries that may ultimately help with diagnosing or treating this disease. Read Less

Obtain blood samples for generation and maintenance of induced pluripotent stem cells (iPSCs) and genomic/DNA sequencing for biomedical research that will improve the understanding and treatment of pediatric cardiovascular disease Read Less

This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health. Read Less

This phase I trial is to find out the best dose, possible benefits and/or side effects of third-party natural killer cells in combination with mogamulizumab in treating patients with cutaneous T-cell lymphoma or adult T-cell leukemia/lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Immunotherapy with third-party natural killer cells, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Mogamulizumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving third-party natural killer cells in combination with mogamulizumab may kill more cancer cells. Read Less

This phase Ib trial seeks to find out the best dose and possible side effects and/or benefits of zanubrutinib in combination with the R-PolaCHP in treating patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). Zanubrutinib is designed to block a protein called Bruton Tyrosine Kinase in order to stop cancer growth. R-CHOP is the acronym for the combination of five drugs: rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone. It is the most widely used chemoimmunotherapy regimen for DLBCL and is considered the standard-of-care treatment for patients with DLBCL. Three of the drugs in R-CHOP (cyclophosphamide, doxorubicin and vincristine) are chemotherapy drugs. Rituximab is a type of immunotherapy and prednisone is a type of steroids. Read Less

The investigators will follow probability-based cohorts of adult non-medical marijuana users (N=1,500; ages 21+) and susceptible adolescents and young adults (AYA) users (N=1,000; ages 15-20) over four years. The investigators will use a prospective survey to collect marijuana use information and will conduct volumetric choice experiments (VCEs) where participants choose quantities to purchase among three legal product prototypes: flower, edible, and concentrate; and one illegal flower product, under simulated retail marijuana tax structures. The presentation of edibles and concentrates will change over time to capture the range of product varieties in the market and to accommodate new products and characteristics as they evolve. Choice experiments including VCEs use a series of manipulations as a measurement device to elicit preferences for products and consumption. Therefore, the experimental design is within-subjects with repeated measures, which allow for causal identifications of the impact of design attributes (e.g., tax bases and rates) on preference and consumption outcomes. The attributes and levels are selected to reflect THC levels in the market, existing (weight, price, tiered price by forms) and novel (potency) tax bases, existing (10%-40% of retail price or equivalent in other bases) and potential (high 60% and 80% of retail prices or equivalent) tax rates, and price distribution for each product. Price distribution levels (5 to 95 percentiles) will come from our price data collection and will be updated over time and vary by participants' state and locality of residence. Before the experiment, study personnel will instruct participants 1) how to answer the choice experiment question, including considering their weekly expenditures when answering VCE questions; 2) that there is no access to other products, no stockpiling, no selling or giving away products to others, etc., to ensure that participants choose products that reflect their usual purchase patterns for self-use; 3) that there are no right or wrong responses. Study personnel will instruct participants to answer all questions honestly, thoughtfully, and to the best of their understanding as if they were actually in this situation, to reduce hypothetical bias; 4) that there may be potential costs or issues associated with purchasing illegal products, including risks of penalties, undefined potency, possible contamination, and inconsistent product quality; and 5) that participants should keep their weekly budget in mind when making purchase choices of the products. In VCEs, the investigators will manipulate THC levels, tax rates and bases, and price levels. Participants will be asked to answer the following: "Imagine these are the marijuana products that you (participants) can purchase for non-medical use, how many of each product would you (participants) most likely buy next time?" Participants can choose more than one product, and as they choose quantities, the total balance will be displayed. To make the tasks easier, study personnel will 1) set a warning to inform participants if their reported budget exceeds their weekly budget for spending; 2) provide a dropdown list for quantities or, if they would like more units than the listed, they can fill in a number; and 3) all products are described as high-quality to allow for a comparison of prices. Half of the participants will be randomized to see itemized pre-tax tag price, excise taxes, and sales taxes, as requested in some states (e.g., Illinois); the other half will be randomized to see only prices that are inclusive of excise taxes. This will allow us to whether excise taxes are more effective when applied at checkout compared to hidden in the tag prices. Read Less

This pilot clinical trial studies transoral robotic surgery (TORS) in treating patients with benign or malignant tumors of the head and neck. TORS is a less invasive type of surgery for head and neck cancer and may have fewer side effects and improve recovery Read Less

This phase I/II trial studies the best dose, possible benefits and/or side effects of oral azacitidine in treating patients with T-cell large granular lymphocytic leukemia that has come back (relapsed) or has not responded to previous treatment (refractory). Chemotherapy drugs, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Read Less

This phase I trial tests the safety, side effects, and best dose of SNDX-5613 and gilteritinib for treating patients with acute myeloid leukemia that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory) and has a mutation in the FLT3 gene along with either a mutation in the NMP1 gene or a type of mutation called a rearrangement in the MLL gene. SNDX-5613 is in a class of medications called menin inhibitors. It works by blocking the action of mutated MLL and NMP1 proteins that signal cancer cells to multiply. Gilteritinib is in a class of medications called tyrosine kinase inhibitors. It works by blocking the action of mutated FLT3 proteins that signal cancer cells to multiply. Giving SNDX-5613 with gilteritinib may be safe, tolerable and/or effective in treating patients with relapsed/refractory FLT3 mutated acute myeloid leukemia. Read Less

The goal of this interrupted time series quasi-experimental design study is to implement universal opt- out HIV testing and linkage to HIV preventive care in 15-21 year old adolescents visiting the pediatric emergency department (ED). The main question\[s\] it aims to answer are: 1. What is the uptake, reach and effectiveness of universally offered, opt-out HIV screening across pediatric EDs after implementing an adapted version of a tablet-based screening process? 2. What is the successful linkage to comprehensive HIV pre-exposure prophylaxis (PrEP) care using a novel, digital health platform? Participants will 1. Complete the previously developed and validated computerized sexual health screen (cSHS) containing questions regarding their personal sexual health history 2. Have the opportunity to opt-out of clinician-ordered HIV testing 3. Patients meeting CDC criteria for HIV PrEP will be given the opportunity to enroll in the digital health PrEP linkage platform and followed for 3 months after enrollment. Read Less